intro to human subjects research - funding.yale.edu...interview, focus group, program evaluation,...
TRANSCRIPT
March 2017
Intro to Human Subjects Research
Cheryl M. Danton MHSIRB Regulatory Analyst
Human Subjects Committee (HSC)/Human Investigation Committee (HIC) III
WHEN do I need to submit my project for IRB review?
WHAT documents will be required?
WHERE do I submit the documents?
HOW do I make changes to an approved study?
What if something goes wrong once I start the study?
What should I do when I am done with the study?
Where do I get help?
Learning Objectives
IRB Decision Tree
IRB Review is not required
Is it Research?
YES
NOIRB Review is not required
Does It Involve Human Subjects?
YES
NO
Does it meet any of the exemption categories?
IRB Review and Approval are requiredNO
YES
Exemption determination is needed
Research
45CFR46.102(d)
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Is My Project/Study “Research”?
https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/#46.102
Quality Improvement (QI) and Quality Assurance (QA) projects are designed to improve clinical care, patient safety, health care operations, services and programs or for developing new programs or services (e.g. teaching evaluations, patient/employee service surveys).
QI/QA is generally NOT generalizable, and is meant to be applicable to a particular setting. Ex: Patient satisfaction surveys to improve a specific clinic’s efficiency Yale University IRB Policy 100. GD.5 Quality Improvement and Quality Assurance Projects
and IRB Review
Oral History “method of gathering and preserving historical information through recorded interviews with participants in past events and ways of life.” Oral History Association (OHA) IRB review not required: Collection of labor/birth stories to create an archive on women’s birth
experiences worldwide IRB review required: Interviews with new mothers comparing cultural norms around labor pain
management Yale University IRB Policy 100. GD.1 Humanities Projects and IRB Review
Examples Of Projects/Studies Not Considered “Research”
If you are working with an institution/organization where the procedures/research would be carried out regardless of your involvement i.e. you are not carrying out independent research AND you are not using the data collected for publication, senior thesis etc, then you do not need to submit to the IRB.
Do I submit a proposal to the IRB if I have an internship?
What is a Human Subject? 45CFR46.102(f)
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains
(1) Data through intervention or interaction with the individual, or
(2) Identifiable private information.
https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/#46.102
Does My Project/Study Include Human Subjects?
Data about health facilities, businesses or organizations that are not individuals. This data can either be obtained by interview OR as a secondary data analysis.
Data on deceased persons
De-identified human data or specimens
What Kind of Data Would NOT Be Considered Human Subjects?
You have determined that your Project/Study requires IRB review, what are your next steps and what documents are required?
Step 1: What level of review is required?
Levels of
IRB Review
http://oprs.usc.edu/review/typesofirb/
What is an Exemption?
•A federally designated category
•Describes certain kinds of minimal risk research
•Means that the research is determined to be exempt from continuing IRB review
Exemption Categories45CFR 46.101(b) 1-6
Category 1-Educational Practices
Category 2 Educational Tests, Interviews, Surveys or Observation of Public Behavior
Category 3 Elected Officials (Educational Tests, Interviews, Surveys or Observation of Public Behavior)
Category 4-Collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens
Category 5-Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine methods and procedures of public benefit or service programs.
Category 6-Taste and food quality evaluation and consumer acceptance studies
Category 7- Research involving interviews, surveys, educational test or observation of public behavior in which participant interaction includes providing a response to a non- physically invasive stimulus or behavioral activities commonly performed outside the research context. Created by Yale University
https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/
What is expedited?
9 research categories:
Most common:
5). Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
7). Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)
https://www.hhs.gov/ohrp/regulations-and-policy/guidance/categories-of-research-expedited-review-procedure-1998/
Log in to IRES-IRB submission system http://ires-irb.yale.edu Click on “Library” to access all IRB documents Exemption Request or full Protocol Application (used for expedited and
full committee protocols) Faculty Advisor Attestation Form Informed Consent Form OR consent script (for verbal consent) Surveys, interview questions, standardized measures, etc. Recruitment materials Letters of Support-if you are working with an organization such as an
NGO or clinic Local IRB Review-for International Research
https://your.yale.edu/policies-procedures/forms/450-ch-1-international-research-checklist
450 GD.1 International Research: Required Documents and Additional Considerations https://your.yale.edu/policies-procedures/guides/450-gd-1-international-research-required-documents-and-additional
Step 2: Determine Appropriate Documents For Submission
Points to remember when developing a research protocol/consent documents
Describe in detail what it is that you are doing and why
Describe your study participants and how you are recruiting them
Include the description of consenting process
Describe risks and benefits of the study
Answer all the questions in the forms
Include all survey questions or possible topics of discussion, when needed
Include all required consent elements – use the template
Make sure you and your faculty advisor have completed human subject protection training, HIPAA (if applicable) and conflict of interest disclosure (for graduate students). Human Subjects Protection Training can be accessed at yale.edu/training
Data Security
Procedure 400 PR.1 Protecting Participants” Research Data
https://your.yale.edu/policies-procedures/procedures/400-pr-1-protecting-participants-research-data
Password protection
Storage on Yale secure server or cloud
Identifying information
Step 3: Submit all documents in IRES IRB
• All IRB submissions for HSC and HIC are required to be submitted through the IRES IRB online submission system: http://ires-irb.yale.edu
• When you log into the system, click on “Help”, which will bring you to a series of quick guides that gives you step by step instructions on how to create a new study.
• Make sure to add your Faculty Advisor as a “PI Proxy” in the system• Email the Fellowship Email, if you have any questions:
Review Process
Within 3 to 4 weeks, a regulatory analyst may contact you with questions
If you have to revise your documents – use track changes!
If the study requires full board review (e.g. it poses greater than minimal risk to participants), it will be scheduled to the next available IRB meeting
Once approved, you will receive a determination/approval letter via email
DO NOT START RESEARCH WITHOUT THE IRB LETTER
Retrospective Review
There is no mechanism for retrospective review of research that was completed without IRB approval.
When things go wrong
Contact your IRB Regulatory Analyst ASAP
Certain unanticipated problems have to be reported right away (e.g. stolen computer with sensitive data)
Minor deviations may wait till annual review (e.g. a participant missed an appointment and did two interviews on the same day even though the protocol includes 2 days of testing)
Research Integrity
Guide to Undergraduate Research (WebGURU)
http://www.webguru.neu.edu/index.php
US Dept. of Health & Human Services: The Office of Research Integrity: General Resources
https://ori.hhs.gov/general-resources-0
When the study is done
When you have completed analysis on identifiable data and the study has an expiration date, you can close it by submitting a Request to Close
IRB does not need to be notified about closures of exempt studies
Do not allow a study to lapse! If you need to continue your research or analysis on identifiable data, then submit a Request to Renew
Collaboration with other researchers
Only people affiliated with Yale and listed on the approved protocol can be engaged in the conduct of Yale study UNLESS they get approval from their IRB or we sign appropriate agreements (e.g. unaffiliated investigator agreement). Contact your regulatory analyst for help.
Where to get help
Contact the HSC office by emailing human.subjects@ yale.edu to set up an appointment
Call the HRPP Office - (203) 785-4688
IRB Regulatory Analysts
Cheryl M. Danton MHS, CIP
(203)-785-6438
Brandy Lagner BA, CIP
(203)-737-4219